The present invention relates primarily to a system and method for facilitating the donning of gloves in an automatic manner such that the user or wearer is not required to manually grasp the gloves during the donning operation. Such a system is of particular use for donning surgical gloves and for donning gloves used in clean rooms in the semiconductor/microprocessor and pharmaceutical industries where avoidance of contamination of gloves is of the highest priority.
The importance of donning surgical gloves or gloves used in semiconductor xe2x80x9cclean roomsxe2x80x9d in a contamination-free manner is well known. The presence of microbial contaminants on the gloves, arising from manual manipulation of the gloves during donning, for example, can have adverse and even lethal effects on a patient undertaking surgery. Similarly, particulate contaminants passed on from a glove can destroy a semiconductor wafer.
Surgeon""s and patient examination gloves are intended to provide an effective barrier against potentially infectious materials and other contaminants. However, the use of such gloves has been associated with a number of adverse health effects in patients and users, including allergic reactions, foreign body reactions and irritation. Natural rubber latex (NRL), from which such gloves are generally made, comprises a variety of naturally occurring substances, including plant proteins, which are believed to be the primary allergens associated with natural latex allergy. Nonetheless, NRL gloves provide users with great sensitivity and no suitable synthetic replacement is currently available. However, NRL gloves are difficult to don and doff, and thus glove powder, which comprises cornstarch as a main component thereof, is often used for lubricating the inside surfaces of the gloves. Natural latex allergens are known to bind to cornstarch, and thus the use of donning powder may be pose an additional hazard for allergic personnel and patients. Over the past 3 years, FDA has received requests to ban the use of all glove powders, due to the indications that cornstarch on surgical gloves can reduce tissue resistance to infection, enhance the development of infection and act as a carrier of natural latex protein from NRL products, among others [Federal Register: Jul. 30, 1999 (Volume 64, Number 146) Proposed Rules, Page 41709-41743 from the Federal Register Online via GPO Access (wais.access.gpo.gov), 21 CFR Parts 801, 878, and 880]. In June 1997, the National Institute of Occupational Safety and Health (NIOSH) of the US issued a safety alert recommending the use of powder-free, reduced protein content or synthetic gloves as a means to reduce exposure to natural latex allergens, specifically via the airborne route of exposure [Department of Health and Human Services (NIOSH), xe2x80x9cNational Institute of Occupational Safety and Health (NIOSH) Alert: Preventing Allergic Reactions to Natural Rubber Latex in the Workplacexe2x80x9d, Publ. No. 97-135, June 1997.]. While the FDA agrees with the goal of reducing exposure to airborne allergens, it is at the same time concerned that efforts to produce powder-free gloves with satisfactory donning properties may require additional manufacturing processes that, if not appropriately controlled, have deleterious effects on physical properties, performance and shelf-life of the gloves [Aziz, N., xe2x80x9cChlorination of Glovesxe2x80x9d Paper No. 5. of the Latex Protein Workshop of the International Rubber Technology Conference, June 1993, Kuala Lumpur, Malaysia; FDA, CDRH, xe2x80x9cEnvironmental Degradation of Latex Gloves: The Effects of Elevated Temperature on Tensile Strengthxe2x80x9d, Division of Mechanics and Materials Science Report # 96-05, D. Walsh, D. Chwirut, R. Kotz, and J. Dawson, Rockville, Md., 1997]. In fact, the FDA is encouraging industry to find a balance between donning requirementsxe2x80x94hitherto met by use of the powderxe2x80x94and reducing the risk of adverse health effects.
Rather than using donning powder, lubrication of the gloves may be provided, instead, by a coating or by chlorination. Various kinds of coating are in use. Their manufacture, like the chlorination process, must be carefully controlled to assure a good bond between the coating and the glove. Since the coatings may have different physical properties from that of the NRL glove, they may not generally have the same stretching characteristics, and thus provide a different xe2x80x9cfeelxe2x80x9d to a user than regular NRL gloves.
Chlorination is widely used for reducing the tackiness of natural latex gloves and thus eliminates the need for donning powder. Chlorination works by degrading the surface of the gloves, and thus the chlorination process must be very carefully controlled to prevent destruction of the glove barrier. Improperly chlorinated gloves rapidly degrade, and breaks in the latex film may occur within a span of a few months.
Another concern is the presence of minute defects in the gloves known as pinholes, which directly affect the barrier integrity of the gloves. Studies show that particles such as dust, dirt and other debris may cause pinholes. Furthermore, the glove manufacturing process may also introduce pinholes due to factors such as former vibration, air bubbles in the dripping tanks, dirty formers, incorrect formulation, excessive curing temperatures, and so on. While manufacturers are supposed to comply to minimum manufacturing standards, and while randomised checks are performed, it is still possible for some gloves not meeting the minimum pinhole criteria to be used, leading to the possibility of viruses penetrating the glove, eliminating or reducing the glove""s effectiveness as a barrier.
An alternative approach to using less effective synthetic gloves, or to providing NRL gloves with less or alternative forms of lubrication to donning powder, is to provide a glove donning system that reduces the need, and preferably does away with the need entirely, for lubrication. Such a donning system would thus enable regular NRL gloves (as well as any similar type of glove) to be donned without lubrication, in particular donning powder, by elastically deforming the inside of the glove to a volume greater than the hand of the user. In particular, such a system requires the cuff of the glove to be elastically expanded to a size such as to facilitate insertion of a hand therethrough and into the body of the glove.
Automatic glove donning devices are known. Typically, a glove to be donned is held in a vacuum chamber such that the cuff section of the glove is open providing communication between the inside of the glove and the environment of the wearer. The outer surface of the glove is exposed to the vacuum chamber, and thus remains substantially uncontaminated by the wearer environment. When a vacuum is applied to the vacuum chamber, the glove expands within the vacuum chamber by virtue of the greater ambient pressure in the wearer environment, sufficiently to permit a user to insert his hand into the extended glove relatively effortlessly, after which the glove is removed from the vacuum chamber donned on the wearer""s hand. Many devices are equipped to don the right-hand and the left-hand gloves from separate dispensers.
These prior art devices, however, comprise inadequate systems for holding the glove within the vacuum chamber in the first place, such as to form an airtight seal between the cuff section of the glove and the chamber. For example, in U.S. Pat. No. 3,695,493, the donning device may only be used with gloves having a cuff portion comprising a special ring made from a rigid material. While the ring permits the glove to sealingly abut against the opening of the vacuum chamber, the device cannot be used with standard gloves, resulting in relatively high running costs for the device. Further, the rigid ring causes difficulties in sealing the cuff portion of the glove onto the wearer""s arm.
In U.S. Pat. No. 4,002,276 and U.S. Pat. No. 4,275,812, the gloves come prepared with the cuff portion stretched over a special dedicated ring. Thus, the device cannot be used with standard gloves adding considerably to the running costs of the device since the unit costs of each glove is considerably higher than for standard gloves. Similarly, U.S. Pat. No. 4,069,913 provides a sterilised glove package unit comprising a glove having its cuff portion stretched over a rigid ring, and sealed in an outer protective bag. U.S. Pat. No. 4,155,494 describes a relatively large diameter annular ring onto which the cuff portion of a glove is stretched over prior to donning. U.S. Pat. No. 5,058,785 requires a relatively large stiffening ring for the glove in order to subject the glove to a vacuum. In U.S. Pat. No. 5,078,308 and U.S. Pat. No. 4,915,272, the cuff portion of an elastic glove must be manually stretched over the opening of a cylindrical vacuum tube before it can be donned. In U.S. Pat. No. 4,889,266, a stacked arrangement of glove cartridges enables cartridges to be transported to the opening of a left-hand and of a right-hand vacuum chambers, each cartridge comprising a polygonal glove holder having an opening into which an elastic glove is received, the cuff portion of which is stretched over a lip.
Some glove donning systems do not make use of a vacuum to inflate the gloves, but nevertheless suffer from similar problems as described above. For example, in U.S. Pat. No. 4,228,935, a wrist portion in the form of a relatively rigid toroidal-like member is receivable in a holding rack for enabling the glove to be donned and removed. In U.S. Pat. No. 4,898,309 regular elastic gloves are manually stretched over the open end of a tubular member facilitating entry of the hand into the glove, but at the same time contaminating the glove in the initial glove stretching process.
All the aforementioned prior art devices either require the manual manipulation of a regular-type elastic glove over a stiff lip or ring, increasing the possibility of contamination of the glove, or alternatively require the gloves to come in prepared packages comprising such a ring, resulting in much higher unit costs for the gloves than with regular gloves.
It is therefore an aim of the present invention to provide a system and method which overcomes the aforementioned limitations of glove donning systems and methods.
It is another aim of the present invention to provide a system for facilitating the donning of gloves in a substantially contamination free manner.
It is another aim of the present invention to provide a system for the donning of gloves which enables elasticated gloves such as NRL gloves to be donned relatively easily without the need for lubrication of the gloves.
It is another aim of the present invention to provide such a system in which standard elastic gloves may be donned in a substantially contamination free manner.
It is another aim of the present invention to provide such a system in which each glove can be checked for leakage, and thus for the existence of pinholes therein, prior to donning.
It is another aim of the present invention to provide such a system that is simple to use.
It is another aim of the present invention to provide such a system that is relatively simple mechanically and thus economic to produce as well as to maintain.
The present invention achieves these and other aims by providing a glove donning system in the form of a glove grasping means, typical a vacuum wand, adapted to grasp the outer skin of the cuff portion of a glove, and means are provided to transport the glove into a vacuum chamber such that the cuff portion of the glove is more-or-less aligned with the perimeter or rim of the opening of the vacuum chamber. By grasping only the outer skin of the glove, the cuff portion is gently opened sufficiently to enable an inflatable ring to be inserted into the cuff portion in the deflated state. The ring is then inflated while positioned inside the cuff portion so that the cuff portion is stretched and expanded until it touches the rim of the vacuum chamber. The rim is provided with a suction ring capable of generating sufficient suction to keep the cuff of the glove pressed against the rim, at which point the inflatable ring may be deflated and removed with the grasping means. With the glove thus held within the vacuum chamber, a vacuum is applied to the chamber inflating the glove and thus enabling a hand to be inserted into the glove. A donning device may be fitted with a pair of such systems, one for each hand, and further provided with suitable means for stacking and delivering on demand one glove to each vacuum chamber.
The present invention relates to a system for expanding a cuff portion of an elastically expandable glove from a non-expanded condition to an expanded open condition and for releasably holding said cuff portion in said open condition, said open condition being at least sufficient to enable a hand to pass through the cuff portion of the glove, the system comprising:
holding means comprising suction means and at least one suitable contact surface for sealingly holding said cuff portion in said open condition when said cuff portion is in abutting contact with said at least one contact surface: and
expandable ring means capable of being reversibly expanded from a first configuration to a second configuration and capable of being contracted from said second configuration to said first configuration, wherein in said first configuration said ring means comprises a compact external profile such as to enable said ring means to be inserted into said cuff portion when said glove is in said non-expanded condition, and wherein in said second configuration said ring means comprises an expanded external profile at least substantially complementary to that of said at least one contact surface to enable the cuff portion to be abutted thereagainst.
Preferably, said holding means are sealing mountable to an open end of a vacuum chamber such that a glove held by said holding means extends into said vacuum chamber, said vacuum chamber being adapted for expanding a portion of said glove extending into said chamber by the application of a vacuum to the external surface of said portion of said glove when said cuff portion is sealing held in said open condition by said holding means.
Optionally, said vacuum means comprises a vacuum chamber operatively connected to a vacuum source and further comprises suction apertures in close proximity to said at least one contact surface for providing suction to at least part of said cuff portion when said cuff portion is in abutting contact with said at least one said contact surface.
Preferably, said at least one contact surface comprises a concave cylindrical surface, and optionally, wherein said holding means comprises first and second axially displaced holding members each having a central aperture comprising at least one said contact surface, wherein said central apertures are substantially coaxially aligned, and wherein said suction apertures are intermediate said at least one contact surface of each said central aperture. Further optionally, said suction apertures are comprised in a suitable mesh, said mesh being axially joined to said first and second holding members.
In a first embodiment, said expandable ring means comprises a substantially toroidal inflatable member capable of being inflated by the application of a pressurised gas at least from said first configuration to said second configuration, and further comprises a pipe in open communication with the interior of the said ring, said pipe being connectable to a suitable pressurised gas source. Preferably, in said first configuration, said ring comprises a substantially flattened transverse profile. Optionally, said ring means further comprises suitable probe means extending downstream of said ring means, said probe in cans having a head comprising at least one nozzle means for directing pressurised gas in a downstream direction, said probe means further comprising a compressed gas line in communication with said probe head, said probe being connectable to a suitable pressurised gas source. Preferably, said head comprises a relatively narrow transverse profile with respect to the transverse profile of said ring means in said first configuration. Typically, said head is insertable in between the substantially flattened opposed surfaces of the said cuff portion when said cuff portion is in a substantially collapsed flattened condition. The probe means is capable of providing compressed gas flow into the glove when at least said head is inserted in-between the substantially flattened opposed surface of the said cuff portion when said cuff portion is in a substantially collapsed flattened condition. The compressed gas flow provided by said head is at least sufficient to separate said opposed flattened surface to enable said ring means in said first configuration comprising a substantially flattened transverse profile to be inserted into said cuff portion.
In the first embodiment, and in said second configuration, said ring comprises a substantially toroidal shape having a transverse diameter at least equal to the internal diameter of said contact surface, and wherein at least a portion of said ring is capable of adopting a profile substantially complementary to said at least one contact surface when in abutting contact therewith directly or indirectly via said cuff portion such as to provide a contact area with said contact surface having a predetermined axial length, typically, between about 10 mm and about 30 mm.
In a second embodiment, said expandable ring means comprises a substantially inflatably stretchable tubular sleeve attached at each end thereof onto a substantially rigid inner member. The sleeve is capable of being inflated by the application of a pressurised gas at least from said first configuration to said second configuration, and further comprises a pipe in open communication with a space between the interior of the said sleeve and the inner member, said pipe being connectable to a suitable pressurised gas source. Optionally, said ring means further comprises suitable probe means extending downstream of said ring means, said probe in cans having a head comprising at least one nozzle means for directing pressurised gas in a downstream direction, said probe means further comprising a compressed gas line in communication with said probe head, said probe being connectable to a suitable pressurised gas source. Preferably, said head comprises a relatively narrow transverse profile with respect to the transverse profile of said ring means in said first configuration. Typically, said head is insertable in between the substantially flattened opposed surfaces of the said cuff portion when said cuff portion is in a substantially collapsed flattened condition. The probe means is capable of providing compressed gas flow into the glove when at least said head is inserted in-between the substantially flattened opposed surface of the said cuff portion when said cuff portion is in a substantially collapsed flattened condition. The compressed gas flow provided by said head is at least sufficient to separate said opposed flattened surface to enable said ring means in said first configuration comprising a substantially flattened transverse profile to he inserted into said cuff portion.
In the second embodiment, and in said second configuration, said sleeve comprises a form similar to an ellipsoid of revolution having a transverse diameter at least equal to the internal diameter of said contact surface, and wherein at least a portion of said sleeve is capable of adopting a profile substantially complementary to said at least one contact surface when in abutting contact therewith directly or indirectly via said cuff portion such as to provide a contact area with said contact surface having a predetermined axial length, typically, between about 10 mm amid about 30 mm.
Optionally, the system of the present invention further comprises cuff-portion inter-surface separation means for separating the substantially flattened opposed surfaces of the said cuff portion when said cuff portion is in a substantially collapsed flattened condition. In the preferred embodiment, said inter-surface separation means comprises a vacuum wand capable of applying suction to a portion of one said flattened opposed surfaces when in close proximity thereto such as to separate this flattened surface from the opposed flattened surface such as to provide an opening in said cuff portion of the glove. Said opening typically comprises a transverse profile sufficiently large to enable said ring means to be inserted into said cuff portion when in said first configuration. The vacuum wand typically comprises at least one suction port and a vacuum line in fluid communication thereto, said vacuum line being connectable to a suitable vacuum source, and the vacuum wand provides a suction force on said one flattened surface sufficient to enable translational and/or rotational motions to be imparted to said glove via said vacuum wand.
In the preferred embodiment, the vacuum wand is mounted onto a first transport means to enable said vacuum wand to he translated and/or rotated within a predetermined working volume. Also7 the ring means is mounted onto a second transport means to enable said ring means to be translated and/or rotated within a predetermined working volume. Preferably, the holding means are comprised within said working volume.
The present invention is also directed to a method for expanding a cuff portion of an elastically expandable glove from a non-expanded condition to an expanded open condition and for releasably holding said cuff portion in said open condition, said open condition being at least sufficient to enable a hand to pass through the cuff portion of said glove, comprising the steps of-
(a) providing holding means;
(b) providing ring means;
(c) inserting said ring means while in said first configuration into the said cuff portion, said cuff portion being in said non-expanded condition;
(d) expanding said ring means to said second configuration such as to expand said cuff portion onto abutting contact with said contact surface, said holding means being suitably aligned with said ring means;
(e) applying suction to said cuff portion via said suction means such as to maintain said cuff portion in contact with said contact surface;
(f) reducing the external profile of said ring means from said second configuration, and removing said ring means from said cuff portion.
Said method optionally further comprises the following steps:
(g) providing said probe means;
(h) inserting said probe means into said cuff portion, said cuff portion being in said non-expanded condition;
(i) providing compressed air into said glove via said probe means such as to separate opposed flattened surface of said cuff portion to enable said ring means to be inserted into said cuff portion, said ring means being in said first configuration comprising a substantially flattened transverse profile.
wherein steps (g) to (i) are performed between steps (b) and (c).
Further, the method optionally further comprises the following steps:-
(j) providing said inter-surface separation means;
(k) placing said suction port of said vacuum wand in close proximity to the external surface of one opposing flattened surface of said cuff portion, said cuff portion being in said non-expanded condition;
(l) providing suction to a part of said external of said one flattened surface of said cuff portion via said vacuum wand such as to separate opposed flattened surfaces of said cuff portion to enable said ring means to be inserted into said cuff portion, said ring means being in said first configuration comprising a substantially flattened transverse profile.
wherein steps (j) to (l) are performed between steps (b) and (g).
Alternatively, steps (g), (h) and (i) are not performed, and steps (j) to (l) are performed between steps (b) and (c).
Optionally, the method further comprises the steps:-
(m) providing said first transport means;
(n) transporting said vacuum wand to a position superposed over said one flattened surface of said cuff portion between step (j) and step (k);
Optionally, the method further comprises the steps:
(o) grasping said cuff portion by means of said vacuum wand and transporting said glove via said first transport means to a position within said holding means such that said cuff portion is aligned with said at least one contact surface prior to step (c);
(p) expanding said ring means to a third configuration intermediate said first configuration and said second configuration, wherein in said third configuration, said ring is expanded sufficiently so as to engage and partially expand said cuff portion;
(q) reducing suction from said vacuum wand such as to disengage from said cuff portion prior to step (d).
The method may further optionally comprise the steps:-
(r) providing said second transport means;
(s) expanding said ring means to a third configuration intermediate said first configuration and said second configuration, wherein in said third configuration, said ring is expanded sufficiently so as to engage and partially expand said cuff portion;
(t) reducing suction from said vacuum wand such as to disengage from said cuff portion;
(u) grasping said cuff portion by means of said ring means and transporting said glove via said second transport means to a position within said holding means such that said cuff portion is aligned with said at least one contact surface prior to step (c).
Preferably, the holding means are sealingly mounted to an open end of a vacuum chamber such that a glove held by said holding means extends into said vacuum chamber, said vacuum chamber being adapted for expanding a portion of said glove extending into said chamber by the application of a vacuum to the external surface of said portion of said glove when said cuff portion is sealing held in said open condition by said holding means.
Such a method may be adapted for donning right handed gloves and/or left-handed gloves to a user.
The present invention also relates to an apparatus for donning elastically expandable gloves comprising:
(i) at least one vacuum chamber having an open end, said vacuum chamber operatively connected to a suitable vacuum source;
(ii) holding means mounted onto said open end;
(iii) ring means.
Optionally, said apparatus further comprises glove dispensing means for enabling at Least one glove to be engaged by said ring means, and inter-surface separation means.
Preferably, said apparatus comprises two said vacuum chambers, wherein one said vacuum chamber is adapted for donning left-handed gloves, and wherein the other said vacuum chamber is adapted for donning right-handed gloves.